Penile Hemodynamic Recovery Following a Six-Month Structured Lifestyle Modification Program in Men With Metabolic Syndrome-Associated Erectile Dysfunction: A Prospective Single-Arm Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in penile peak systolic velocity from baseline to six months
研究概览
简要总结
Metabolic syndrome is associated with erectile dysfunction through obesity, insulin resistance, abnormal blood lipids, high blood pressure, and impaired blood-vessel function. This study will evaluate whether a structured six-month lifestyle-modification program can improve penile blood flow and erectile function in men with metabolic syndrome-associated erectile dysfunction.
Eligible participants will receive dietary counseling, exercise guidance, weight-management advice, smoking-cessation counseling when applicable, sleep and sedentary-behavior advice, and repeated behavioral reinforcement. Erectile function, penile blood-flow measurements obtained by penile duplex Doppler ultrasonography, body measurements, and selected metabolic laboratory parameters will be assessed before the program and after six months.
详细描述
This prospective single-arm interventional study will evaluate the effect of a structured six-month lifestyle-modification program on penile hemodynamic parameters and erectile function in adult men with metabolic syndrome-associated erectile dysfunction.
Participants will undergo baseline assessment including demographic and clinical data collection, anthropometric measurements, blood-pressure assessment, erectile-function evaluation using the International Index of Erectile Function-5, selected laboratory investigations, and penile duplex Doppler ultrasonography after intracavernosal administration of a vasoactive agent according to the local institutional protocol.
The lifestyle program will include individualized dietary counseling, recommendations for regular moderate-intensity aerobic physical activity, weight-reduction advice, smoking-cessation counseling for smokers, sleep-hygiene counseling, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits. Participants will be followed monthly for adherence reinforcement and will undergo repeat clinical, laboratory, erectile-function, and penile hemodynamic assessments at six months.
The principal hypothesis is that structured lifestyle modification will improve penile hemodynamic parameters, particularly peak systolic velocity, and will improve erectile-function scores in men with metabolic syndrome-associated erectile dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 30-65 years.
- •Erectile dysfunction present for at least six months.
- •International Index of Erectile Function-5 score of 21 or less.
- •Metabolic syndrome diagnosed according to the International Diabetes Federation criteria.
- •Sexually active participants in a stable sexual relationship.
- •Willingness and ability to participate in the six-month lifestyle-modification program.
- •Ability to provide written informed consent.
排除标准
- •Erectile dysfunction primarily attributable to neurogenic, psychogenic, hormonal, or postsurgical causes.
- •Severe hypogonadism requiring immediate testosterone-replacement therapy.
- •Use of phosphodiesterase type 5 inhibitors, intracavernosal injections, vacuum erection devices, or other erectile-dysfunction treatment that cannot be discontinued before baseline assessment.
- •Significant penile anatomical abnormality that may interfere with penile duplex Doppler assessment, including Peyronie disease.
- •Previous pelvic surgery or pelvic radiotherapy likely to affect erectile function.
- •Severe or unstable cardiovascular disease that precludes sexual activity or participation in exercise-based lifestyle modification.
- •Uncontrolled diabetes mellitus, defined in the protocol as HbA1c greater than 10%.
- •Uncontrolled hypertension despite medical therapy.
- •Severe renal or hepatic impairment.
- •Active malignancy or life expectancy of less than one year.
- •Major psychiatric illness, cognitive impairment, or inability to comply with study procedures or follow-up.
- •Inability or refusal to provide written informed consent.
研究组 & 干预措施
Structured Lifestyle Modification
Participants will receive a structured six-month lifestyle-modification program consisting of dietary counseling, moderate-intensity physical-activity advice, weight-management counseling, smoking-cessation counseling when applicable, sleep-hygiene advice, reduction of sedentary behavior, and monthly behavioral reinforcement.
干预措施: Structured Lifestyle Modification Program (Behavioral)
结局指标
主要结局
Change in penile peak systolic velocity from baseline to six months
时间窗: Baseline and six months after initiation of the lifestyle-modification program.
Change in peak systolic velocity measured in centimeters per second by penile duplex Doppler ultrasonography after intracavernosal vasoactive-agent administration, comparing the baseline value with the six-month post-intervention value.
次要结局
- Change in resistive index(Baseline and six months.)
- Change in body weight(Baseline and six months.)
- Change in waist circumference(Baseline and six months.)
- Change in end-diastolic velocity(Baseline and six months.)
- Change in International Index of Erectile Function-5 / Sexual Health Inventory(Baseline and six months)
研究者
Abul-fotouh Ahmed
Professor of Urology
Al-Azhar University